Actively Recruiting
Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients
Led by Shaogang Wang · Updated on 2025-02-19
180
Participants Needed
3
Research Sites
332 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if neoadjuvant intravesical instillation of mitomycin C combined with en-bloc surgery works to treat high-risk non-muscle-invasive bladder cancer (NMIBC) patients. It will also learn about the safety of neoadjuvant intravesical instillation of mitomycin C. The main questions it aims to answer are: Does neoadjuvant intravesical instillation of mitomycin C heighten the 1-year recurrence-free survival (RFS) rate for high-risk non-muscle-invasive bladder cancer (NMIBC) patients? What medical problems do participants have when taking neoadjuvant intravesical instillation of mitomycin C? Researchers will compare neoadjuvant intravesical instillation of mitomycin C to a placebo (normal saline) to see if neoadjuvant intravesical instillation of mitomycin C works to treat high-risk NMIBC. Participants will: Take neoadjuvant intravesical instillation of mitomycin C or a placebo twice，1 day and 4 hours before en-bloc surgery Visit the clinic once every 8 weeks for checkups and tests Keep track of the recurrence and progression of the tumor.
CONDITIONS
Official Title
Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and agree to complete all trial procedures
- Male or female aged 18 to 75 years inclusive
- ECOG performance status score of 0 or 1
- Confirmed diagnosis of non-muscle-invasive bladder cancer by imaging and pathology
- Classified as high-risk NMIBC according to EAU Guidelines (2024 edition) excluding extremely high-risk group
- Willing to provide last cystoscopy biopsy specimen or specimens from previous recurrence surgery
- At least 6 weeks since previous anti-tumor treatments before first trial administration
- Suitable organ and blood function with specific laboratory values within defined limits
- Male participants agree to use effective contraception during treatment and for 180 days after last treatment; females of childbearing age have negative pregnancy test within 72 hours before first instillation and agree to contraception during treatment and for 180 days after surgery
You will not qualify if you...
- Primary tumor in upper urinary tract urothelial carcinoma (renal pelvis or ureter)
- Malignant tumors other than bladder urothelial carcinoma within 5 years before enrollment, except specified low-risk cancers
- Active autoimmune diseases requiring systemic treatment within past 2 years (except replacement therapy)
- Major surgery planned during study or within 4 weeks before dosing without full recovery
- Unresolved immune-related toxicity from previous cancer treatments above specified grades
- HIV infection or history of HIV or other acquired immunodeficiency diseases
- Long-term antiviral medication needed for hepatitis B or C with active infection markers
- Uncontrolled systemic diseases such as cardiovascular, cerebrovascular diseases, or diabetes
- History of organ or stem cell transplantation
- Heart failure classified as NYHA Class III-IV
- Significant pulmonary disease causing symptoms at rest or with mild activity
- Other underlying diseases that prevent use of study medication or interfere with diagnosis
- Serious infections before dosing
- Alcohol dependence or drug/substance abuse history within last year
- Clear neurological or psychiatric disorders affecting compliance
- Pregnancy or breastfeeding
- Known allergy or intolerance to intravenous mitomycin or excipients
- Investigator deems participant unsuitable for other reasons
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Trial Site Locations
Total: 3 locations
1
The central Hospital of wuhan
Wuhan, Hubei, China, 430000
Actively Recruiting
2
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
3
Xiangyang Central Hospital
Xiangyang, Hubei, China
Actively Recruiting
Research Team
Y
Yang Xun, Doctor of Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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